This invention relates to the use of tagatose to improve one or more specific blood factors in persons suffering from, or having propensities toward, diseases associated with abnormalities in key blood factors.
A variety of diseases is caused by or results in abnormalities in key blood factors. These factors include red blood cell count (RBC), prothromin time (PT), activated partial thromboplastin time (APTT), and fibrinogen (FIB).
In 13-week studies performed with normal rats, four test groups were placed on normal diets in which 5, 10, 15 or 20 percent by weight, respectively, was replaced with tagatose. Two control groups were included, one maintained on normal diet with no replacement; the other on normal diet in which 20 percent by weight was replaced with cellulose and fructose at 10 percent each.
At the end of the study, all animals were sacrificed and hematological analyses performed on each. The results of these analyses are shown in Table 1. The table demonstrates that the inclusion of tagatose in the diet proved advantageous for each of the above parameters. The RBC and FIB factors for those animals fed tagatose were each increased over the corresponding measurements in the control animals. The increased values were within, or near, the normal range. The PT and APTT values decreased over the study period, staying within the normal range.
Specifically, increases in RBC indicate improved hematopoiesis and better maintenance of the blood and its functions. The decreases in PT and APTT, and the increase in FIB are measures of quicker and better clotting of the blood.
The food additive and new drug regulations of the U.S. FDA endorse the use of rats as good models for the human systems in safety and efficacy studies.
TABLE 1 ______________________________________ Hematological Values RBC, .times.10.sup.6 PT,s APTT,s FIB mg/dl ______________________________________ 0% Control Male 10.9 .+-. 1.1 18.7 .+-. 2.2 260.7 .+-. 40.0 Female 9.8 .+-. 0.6 15.1 .+-. 1.9 228.4 .+-. 77.1 Cellulose/ fructose control Male 11.9 .+-. 1.6 19.9 .+-. 3.1 249.9 .+-. 37.3 Female 9.8 .+-. 0.4 14.4 .+-. 1.8 187.9 .+-. 46.2 5% D-tagatose Male 11.3 .+-. 1.2 19.5 .+-. 1.7 254.5 .+-. 45.2 Female 10.1 .+-. 0.4.sup.c 15.6 .+-. 1.7.sup.c 216.0 .+-. 115.8 10% D-tagatose Male 11.1 .+-. 0.9 18.9 .+-. 2.0 275.3 .+-. 66.2 Female 9.6 .+-. 0.8 14.3 .+-. 1.4 229.9 .+-. 82.0 15% D-tagatose Male 10.7 .+-. 0.9.sup.c 18.7 .+-. 3.0 319.4 .+-. 113.3.sup.a,d Female 9.8 .+-. 0.7 13.7 .+-. 1.1.sup.c 236.0 .+-. 52.9.sup.c 20% D-tagatose Male 10.7 .+-. 0.9.sup.c.sup.a 18.6 .+-. 2.4 290.3 .+-. 49.0.sup.c Female 9.5 .+-. 0.7 13.4 .+-. 1.3.sup.b 261.4 .+-. 50.3.sup.a,d ______________________________________ Note. Values are means .+-.SD (n = 18-20 rats). Hematology abbreviations are defined in the text. Unit abbreviations; g/dl (grams/deciliter), mg/dl (milligrams/deciliter), fl (femtoliter), pg (picogram), s (seconds). Levels of statistical significance indicated by superscript letters. .sup.a Mean significantly different than 0% control (P .ltoreq. 0.05). .sup.b Mean significantly different than 0% control (P .ltoreq. 0.01). .sup.c Mean significantly different than cellulose/fructose control (P .ltoreq. 0.05). .sup.d Mean significantly different than cellulose/fructose control (P .ltoreq. 0.01).